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drugset / Trial / NCT05517564

First-in-Human Study of GM-60106 in Healthy Adults and Otherwise Healthy Adults With an Increased Body Mass Index and Markers of Non-Alcoholic Fatty Liver Disease

NCT05517564 ↗

Phase 1 Unknown 96 enrolled JD Bioscience Inc. Novotech (Australia) Pty Limited · collab
RandomizedSequentialQuadruple-blindTreatment

Summary

This is a Phase 1a/1b, randomised, double-blind, placebo-controlled single- and multiple-ascending dose study to evaluate the safety, tolerability, PK, and PD of GM-60106 in healthy adult male and female participants and otherwise healthy adults who have an increased BMI and markers of NAFLD.

Timeline

Start
2022-08-01
Primary completion
2023-02-28
Completion
2023-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject GM-60106 Unknown 2.5 mg Oral
Subject GM-60106 Unknown 5 mg Oral
Subject GM-60106 Unknown 10 mg Oral
Subject GM-60106 Unknown 20 mg Oral
Subject GM-60106 Unknown 40 mg Oral
Subject GM-60106 Unknown 60 mg Oral
Subject GM-60106 Unknown 100 mg Oral

Indications

metabolic dysfunction-associated steatohepatitis